The Food and Drug Administration has new tools to hold drug companies accountable for promises they make about medications. But the agency has yet to show its hand in using this new power.
Following confirmatory studies that didn't prove Makena's efficacy, the FDA's Center for Drug Evaluation and Research recommended pulling the drug from the market in October 2020. But because the drugmaker didn't voluntarily withdraw the drug, a hearing to discuss Makena's potential withdrawal was required. It took two years for the FDA's advisory committee to meet, and members voted in favor of removing it from the market.
Still, the law doesn't outright require that studies confirming efficacy of a medication be underway at the time of approval. It only says FDA leaders"may require" it.
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